Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects and Subjects With Chronic Liver Disease
Tracking Information
Start Date ICMJE | December 2008 |
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Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: October 28, 2008) | Blood samples [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00781430 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 28, 2008) | Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects and Subjects With Chronic Liver Disease |
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Official Title ICMJE | An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Neratinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults |
Brief Summary | The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease. |
Detailed Description | |
Study Phase | Phase I |
Study Type ICMJE | Interventional |
Study Design ICMJE | Other, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Condition ICMJE | Hepatic Insufficiency |
Intervention ICMJE | Drug: Neratinib (HKI-272) |
Study Arms / Comparison Groups | 1: Experimental Intervention: Drug: Neratinib (HKI-272) |
Recruitment Information
Estimated Enrollment ICMJE | 27 | ||||
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Estimated Completion Date | March 2009 | ||||
Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria for both study populations:
Exclusion criteria for both study populations:
Other inclusion and exclusion criteria apply. | ||||
Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00781430 | ||||
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Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||
Study ID Numbers ICMJE | 3144A1-1111 | ||||
Study Sponsor ICMJE | Wyeth | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Wyeth |
Source: http://clinicaltrials.gov/